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Elasticated Wrist Wrap
EUDAMEDClass I (EU MDR)
Ref FT-685(1)Model FORTUNA -ELASTICATED WRIST WRAP
Identity
- Trade Name
- ELASTICATED WRIST WRAP EUDAMED
- Device Name
- FORTUNA -ELASTICATED WRIST WRAP EUDAMED
- Model / Reference
- FORTUNA -ELASTICATED WRIST WRAP EUDAMEDFT-685(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422646 EUDAMED
- Basic UDI-DI
- 506098242FT-685(1)77 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Elasticated Wrist Wrap by Fima Global Brands Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506098242FT-685(1)77 | Class I | Active |
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Manufacturer
- Manufacturer
- Fima Global Brands Ltd
- EUDAMED SRN
- UK-MF-000036604
- Authorised Representative
- GLORY-Cosmetic Hungary Kft. HU-AR-000035374
Sources (1)
- EUDAMED ae18cf38-c96d-4ec9-aa49-2bac7214e579 61 fields · synced Jun 17, 2026